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Field Safety Notices (FSNs) from 25 to 29 December 2023

Medicines Healthcare Products Regulatory Agency

January 5
15:14 2024

Overview

If you receive a field safety notice (FSN) from a manufacturer you must always act on it.

MHRA publishes the following for information only.

If you have a question about a particular FSN contact the manufacturer.

Latest FSNs

View the latest FSNs

View a list of FSNs published since January 2020

View FSNs since November 2014. FSNs before this date are on the National Archives website

Beckman Coulter: iQ200 Series / DxU 850m/840m

22 December 2023

Urine analyser IVD, laboratory

Model: iQ200 2G-60 MICROSCOPY MODULE, TESTED: 700-3320
iQ200 ELITE TESTED: 700-3370
iQ200 SELECT 2008 TESTED: 700-3345
iQ200 SELECT 2008 INSTRUMENT: 700-3347
iQ200 ELITE INSTRUMENT Non ROHS COMPLIANT: C10683
iQ200 ELITE 2008 TESTED: 700-3375
iQ200 SPRINT 2008 TESTED: 700-3325
iQ200 SELECT INSTRUMENT Non ROHS COMPLIANT: C10684
Instrument, DxU 850m Iris: C49513
Instrument, DxU 840m Iris: C76947
Rev 2 Flow Cell Capsule Spare: C04154
iQ Waste Well Adapter: 700-3393
iQ Clear Kit for iQ SPRINT: 800-3565
iQ Clear Kit for iQ SELECT: 800-3566

MHRA reference: 27752369

Philips: Philips BrightView, X, XCT

14 December 2023

Full-body AMI system

Model: 882480, 882478, 882482

MHRA reference: 27756859 2023/012/019/601/079

Philips: Philips BrightView, X, XCT

21 December 2023

Model: 882480, 882478, 882482

MHRA reference: 27756301 2023/012/004/601/063

Published 5 January 2024

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